Isis Pharma partner submits FDA marketing approval app for Kynamro

CARLSBAD -- Isis Pharmaceuticals Inc.
said Thursday
that an NDA marketing application for its flagship cholesterol drug Kynamro has been filed with the US FDA by Genzyme, a Sanofi subsidiary and Isis' partner for the drug.

Kynamro, generically called mipomersen, reduces the level of blood lipoproteins associated with heart disease. The application asks to sell Kynamro for treatment of homozygous familial hypercholesterolemia. Isis and Genzyme are also testing Kynamro for severe heterozygous familial hypercholesterolemia.

Isis said it will get a $25 million milestone payment from Genzyme for the filing. A marketing application for Kynamro has already been filed in Europe.